A Subtle Test Of Ethics

More than 30 years ago, a New York doctor experimented with a new vaccine by deliberately exposing retarded children to a hepatitis virus at the Willowbrook institution on Staten Island in New York City. Despite laws and new ethical standards that resulted from this scandal, a class-action suit filed last month in Rapid City, S.D., charges the federal government with illegally using as many as 250 Indian children to test the safety of an unlicensed hepatitis vaccine.

Such cases are rare and explosive. Rare, in part, because of the stiff regulations adopted since the days of Willowbrook. Explosive because of incidents such as the 40-year ``Tuskegee Study,`` in which black men with syphilis were observed, but not treated, even after penicillin was found to be effective against the disease.

``There`s a problem with doing research with minorities because they have felt themselves to be more targeted for research,`` said Arthur Caplan, a medical ethicist at the University of Minnesota. ``And the question comes up of whether the selection of subjects is influenced by race, by economic class, by convenience.``

But unlike the Tuskegee and Willowbrook cases, many of the questions surrounding this study are subtle, involving questions of whether the government did enough to explain the possible risks, even if those risks were as small as officials say.

Some of the literature given to parents acknowledged the project was a test of the vaccine and encouraged them to contact the agencies performing the vaccinations if any side effects developed. But the literature did not say the project was a safety test of the vaccine, even though internal federal documents called it a test of safety and effectiveness.

One internal document shows safety clearly was an issue. The memo recommends changes in a letter sent to parents who volunteer their children for the test. The memo says ``since this protocol is also looking into safety, the absolute statement should not be made that this vaccine `has been shown to be safe.` `` So the letter to parents was changed to say: ``Although it is not yet licensed, this vaccine has been given to more than 1,000 adults and children and so far has been shown to be safe. No serious side effects have been observed.``

Another letter used to recruit volunteers for the vaccination is more problematic. It states: ``The purpose of this project is to prevent hepatitis A in Indian and non-Indian children.`` That is not entirely true, acknowledged Dr. William Freeman of Tucson, Ariz., director of research for the Indian Health Service, a defendant in the suit. The main purpose was to study the effectiveness of the vaccine.

Language barriers on the reservations added to the problems, said Bruce Ellison, an attorney for the plaintiffs. Some of the members of the Standing Rock and Pine Ridge reservations, where the tests were performed, speak primarily Lakota. The literature was in English. Health officials respond that staff members explained the test in Lakota and that a video in Lakota also was provided.

And then there was the method of informing parents of the tests. Many parents learned of it from information their children brought home from school.

Federal officials say the vaccine has had a strong safety record in previous federally approved tests, though further testing is necessary before it can be licensed. Only half the volunteers in the program received the hepatitis A vaccine. The other half, a control group, received injections of a federally approved hepatitis B vaccine.

The new product, developed by SmithKline Beecham Pharmaceuticals, has been tested in animals. It then went through two other federally approved testing phases involving adult human beings, Freeman said. It has been tested in more than 200 children in Europe and more than 1,000 adults in the United States and other countries with no major safety problems, he said.

Why choose the reservations for such tests? Because hepatitis A has been a problem on reservations, officials say.

Federal guidelines require that such tests be done only where they can help solve a health problem. Studies show that by age 25, 80 percent of the members on the Pine Ridge and Rosebud reservations in South Dakota have been infected with hepatitis, Margolis said. (The tribal council at Rosebud voted not to participate in the study. Since the controversy started, testing has stopped at Pine Ridge and Standing Rock, though tests continue in Rapid City.) None of these explanations has satisfied the tribal members, who hope a federal judge in Rapid City will order the Indian Health Service to stop testing and soliciting volunteers for further tests.